Requests for authorised prescriber endorsement

The Authorised Prescriber Scheme allows authorised medical practitioners to supply therapeutic goods (such as medicines, medical devices or biologicals) that are not included in the Australian Register of Therapeutic Goods (ARTG) to a class of patients with a particular medical condition.

On 24 July 2020, the TGA implemented a change to the Authorised Prescriber scheme to streamline the application process for medicines considered to have an established history of use in Australia. The application form and process have been updated for medical practitioners to apply under the new arrangements.

This change removes the requirement for Human Research Ethics Committee (HREC) approval or specialist college endorsement to be submitted to the TGA in circumstances where the medical practitioner is applying to become an Authorised Prescriber of medicines specified in subregulation 12B(1B) of the Therapeutic Goods Regulations 1990. A printable version is available on the TGA Authorised Prescriber website

A medical practitioner will still need to obtain prior HREC approval or specialist college endorsement for products that are not included in subregulation 12B(1B) of the Therapeutic Goods Regulations 1990.

Further details on applying for approval/endorsement are available on the TGA Authorised Prescriber website

To apply to the St Vincent’s Hospital (Sydney) HREC for endorsement to apply to the TGA as an Authorised Prescriber, clinicians are required to submit the following:

  • Completed application for HREC endorsement for the purpose of becoming an Authorised Prescriber which is available on the Standard Forms and Templates page. This is required for both new and renewal applications
  • Consumer medical information if the product is approved in another country
  • Relevant literature regarding product use
  • For devices, a copy of the manufacturer instructions for use
  • For renewal applications, 6 monthly reports which have been submitted to the TGA
  • Any other documents relevant to submission